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INSTRUCTIONS
USA: CAUTION: Federal law restricts this device to sale by or on the order of a physician.
Addendum EVIS EXERA II BRONCHOVIDEOSCOPE
BF-1TQ180 1 Instructions The sections below provide updated information or instructions on the chemicals to be used for reprocessing, rinsing after high-level disinfection, and recommendation on using sterilization. Changes are summarized below and are denoted by underlined text in the subsequent sections of this Addendum. #1 Clarification of regulator jurisdiction of the chemicals (for all the listed models) described in Chapter 2, “2.3 Disinfectant solution” in the reprocessing manual is updated to be more accurate description. #2 Recommendation on using sterilization instead of disinfection (for all the listed models) is added to Chapter 3, “3.2 Cleaning, disinfection and sterilization procedures” in the reprocessing manuals from an infection control perspective. #3 Rinsing steps after high-level disinfection (for all the listed models) described in Chapter 3, “3.7 Rinsing after high-level disinfection” in the reprocessing manual is updated to align with the disinfectant manufacture’s instruction. Other parts of the instruction manual are not changed.
2 “2.3 Disinfectant solution” in Chapter 2 In the U.S., agents used to achieve high-level disinfection are defined as liquid chemical germicides regulated by the U.S. Food and Drug Administration as “sterilant/disinfectants” that are used according to the time, temperature, and dilution recommended by the disinfectant manufacturer for achieving high-level disinfection. These conditions usually coincide with those recommended by the disinfectant manufacturer for 100% kill of mycobacterium tuberculosis. In general, 2 – 3.5% glutaraldehyde solutions, when used according to the manufacturer’s instructions for achieving high-level disinfection, are compatible with Olympus endoscopes. If the disinfectant solution is reused, routinely check its efficacy with a test strip according to the manufacturer’s recommendations. Do not use solutions beyond their expiration date.
NOTE For further information regarding the compatibility of glutaraldehyde-based or non glutaraldehyde-based disinfectant solutions, contact your local Olympus organization.
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3 “3.2 Cleaning, disinfection and sterilization procedures” in Chapter 3 After the procedure, clean, disinfect and sterilize the endoscope according to the procedure described below.
Endoscope reprocessing summary chart Withdrawal of the endoscope
Precleaning (Section 3.3 on page 27)
Leakage testing (Section 3.4 on page 31)
Manual cleaning (Section 3.5 on page 35)
High Level Disinfection*1 (Section 3.6 on page 44)
Sterilization (Section 3.8 on page 49)
Rinsing after high-level disinfection (Section 3.7 on page 46)
Storage and Disposal (Chapter 5)
*1 Sterilization can be selected for the scope as a preferable reprocessing method instead of high level disinfection if sterilization is recommended based on decision by medical professionals.
WARNING ALL channels of the endoscope MUST be cleaned and high-level disinfected or sterilized during EVERY reprocessing cycle, even if the channels were not used during the previous patient procedure. Otherwise, insufficient cleaning and disinfection or sterilization of the endoscope may pose an infection control risk to the patient and/or operators performing the next procedure with the endoscope.
4 “3.7 Rinsing after high-level disinfection” in Chapter 3 WARNING After reprocessing, purge the channels of the endoscope to thoroughly dry them. Otherwise, bacteria may proliferate in the channels and pose an infection control risk to the patient and/or operators performing the next procedure with the endoscope. After high-level disinfection, rinse the endoscope and all equipment according to the procedures described below. Use water of appropriate microbiological quality. Once removed from disinfectant solution, the instrument must be thoroughly rinsed with sterile water to remove any residual disinfectant. If sterile water is not available, fresh, potable tap water or water that has been processed (e.g., filtered) to improve its microbiological quality may be used with 70% ethyl or isopropyl alcohol rinse (see “Nonsterile water rinse and alcohol flush” on page 49). Consult your hospital’s infection control committee.
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Equipment needed Prepare the following equipment, and wear appropriate personal protective equipment. • Personal protective equipment • Sterile large basins with tight-fitting lids • Sterile water for sterile water rinse • Sterile, lint-free cloths • Suction pump with sterile suction tube • Suction cleaning adapter
(MAJ-222)
If sterile water is not available, prepare the following equipment. • Clean water for nonsterile water rinse • Small basin with a tight-fitting lid • 70% ethyl or isopropyl alcohol • Sterile cotton swabs
CAUTION Alcohol is flammable. Handle with care.
Sterile water rinse 1 Fill a basin with sterile water. Use a basin that is at least 40 cm by 40 cm (16” by 16”) in size and deep enough to completely immerse the endoscope.
2 Immerse the endoscope and suction cleaning adapter in the sterile water. Use a sterile, lint-free cloth to thoroughly rinse and wipe all external surfaces.
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Connect the suction cleaning adapter and suction pump to the endoscope. Turn the suction pump ON. Aspirate sterile water for 30 seconds. Remove the endoscope from the sterile water and aspirate air for 60 seconds. Turn the suction pump OFF. Place the endoscope and suction cleaning adapter in the sterile large basin. Hold the control section with the instrument channel port pointing down and disconnect the suction cleaning adapter from the endoscope (see Figure 3.19). Suction cylinder Suction cylinder cap Instrument channel port Port cap
Suction opening
Figure 3.19
9 Repeat Step 1 through 8 above for the necessary number of times described in the disinfectant manufacturer’s instructions with new rinsing water.
10 Use a sterile, lint-free cloth to thoroughly wipe and dry the external surfaces of the endoscope and suction cleaning adapter.
11 Store the components following the instructions as described in Chapter 5, “Storage and Disposal”. NOTE Flushing the channels with 70% ethyl or isopropyl alcohol after rinsing them with sterile water facilitates drying inside the channels.
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Nonsterile water rinse and alcohol flush 1 Fill a basin with clean water. Use a basin that is at least 40 cm by 40 cm (16” by 16”) in size and deep enough to completely immerse the endoscope.
2 Immerse the endoscope and suction cleaning adapter in the clean water. Use a sterile, lint-free cloth to thoroughly rinse and wipe all external surfaces.
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Connect the suction cleaning adapter and suction pump to the endoscope. Turn the suction pump ON. Aspirate clean water for 30 seconds. Remove the endoscope from the clean water and aspirate air for 60 seconds. Fill a small basin with 70% ethyl or isopropyl alcohol. Immerse the distal end of the endoscope in 70% ethyl or isopropyl alcohol, and aspirate alcohol for 5 seconds. Remove the distal end of the endoscope from the alcohol and aspirate air for 20 seconds. Turn the suction pump OFF. Hold the control section with the instrument channel port pointing down and disconnect the suction cleaning adapter from the endoscope (see Figure 3.19).
10 Repeat Step 1 through 9 above for the necessary number of times described in the disinfectant manufacturer’s instructions with new rinsing water.
11 Use a sterile, lint-free cloth moistened with alcohol to thoroughly wipe the external surfaces of the endoscope and suction cleaning adapter.
12 Use sterile cotton swabs to dry the inside of the suction cylinder and instrument channel port. 13 Dry the endoscope and suction cleaning adapter. 14 Store the components following the instructions as described in Chapter 5, “Storage and Disposal”.
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